Contraception and pregnancy in microbicide trials.

The distinctive feature of the human immunodeficiency virus (HIV) epidemic in Sub-Saharan Africa is the burden on women, in particular young women of reproductive age. Consequently, most late-phase effectiveness microbicide clinical trials are conducted in sub-Saharan Africa where fertility rates are high. Because late-phase clinical trials are conducted over prolonged periods of time, women participating in these trials may fall pregnant during the trial. Their unborn babies may be exposed to a drug whose teratogenic potential is unknown if the investigational drug is not withdrawn. High pregnancy rates in such trials may compromise statistical integrity, as women will be withdrawn from the study drug for the duration of the pregnancy. It is therefore imperative for microbicide trials to implement effective contraceptive and pregnancy management programmes that maintain low pregnancy rates and the safety of unborn babies while not compromising the conduct and statistical integrity of the trial.